RecruitingPhase 4ACTRN12614000542695

Does melatonin help children with Attention Deficit Hyperactivity Disorder (ADHD) sleep better?

Does melatonin reduce sleep onset latency compared to placebo in children with ADHD on stimulant medication?

Sponsor

The University of Queensland

Enrollment

300 participants

Start Date

Jun 2, 2014

Study Type

Interventional

Conditions

Insomnia ADHD

Summary

Methodology Randomised, Double-Blind, Placebo-Controlled, Multi-Centre trial of aggregated N-of-1 Trials compared to parallel group RCT on the Effects of melatonin on SOL in children and adolescents with ADHD who are receiving stimulant medication. Study Duration 6 weeks (3 pairs over a six week period) for each individual participant Objectives Hypotheses: 1) Melatonin is effective for alleviating initial insomnia in ADHD children who are receiving stimulant medication; and 2) N-of-1 trials provide a similar estimate of treatment effect with less uncertainty than a parallel group RCT. Objectives: 1) To determine the efficacy of melatonin in shortening sleep latency times in children with ADHD treated with stimulants 2) To determine whether n-of-1 trials provide similar estimate of treatment effect with less uncertainty than a parallel group RCT Number of Participants 300 participants (children), 300 parent/guardians from Queensland and Canada

Eligibility

Sex: Both males and femalesMin Age: 6 YearssMax Age: 17 Yearss

Inclusion Criteria6

Children and adolescents between 6 and 17 years.
Diagnosis of ADHD according to DSM- IV or V criteria.
On a stable dose of stimulant (e.g., Ritalin (registered trademark), Ritalin LA, Concerta (registered trademark) for at least 1 month prior to the study.
SOL of 45 min or more, 3 or more nights/week, for 1 month or more as confirmed by parent/guardian.
If previously on melatonin, have ceased it at least two weeks previously.
Informed consent by parent/guardian and by child (if 12 years and over).

Exclusion Criteria27

Children with co-morbid psychiatric/neurological diagnoses that may affect sleep, including:
a) autism/pervasive development disorder
b) brain injury
c) cerebral palsy
d) uncontrolled major depression
e) migraines
f) posttraumatic stress disorder
g) psychosis or schizophrenia
h) seizure disorder (i.e. seizure in the last 12 months)
Children with any of the following disorders of sleep:
a) Untreated Obstructive Sleep Apnea
b) Untreated Sleep Related Breathing Disorder (any form of trouble during sleep associated with breathing, such as need for oxygen, underlying lung disease outside of stable asthma)
c) Untreated narcolepsy
d) Sleep related movement disorders (head banging or body rocking that results in insomnia)
e) Parasomnias (current, regular sleep walking or night terrors)
f) Adjustment insomnia (acute – related to hospitalization, travel etc)
g) Insomnia due to drug use, or mental health issue
h) Secondary enuresis
Known allergy or hypersensitivity to melatonin or other study drug ingredients; Mannitol, Dextrose, Cellulose, Crospovidone, Calcium Carbonate, Xylitol, Dicalcium Phosphate, Vegetable Stearic Acid, Vegetable Magnesium Stearate, Silica
Children on immunosuppressive drugs, blood pressure drugs, SSRIs or anticoagulant drugs;
Children not on regular sedatives or hypnotics whose parents do not agree not to commence these treatments regularly during the course of the trial.
Parents of children on sedatives or hypnotics who do not agree not to alter the daily dose of these for the duration of the trial.
Patients with active or uncontrolled hormonal disorders, or diabetes, or active liver disease, or abnormal kidney function or untreated kidney disease, or any blood clotting disorders;
Participants who disagree to not driving or operating heavy machinery within 8 hours of ingestion of study medication;
Breastfeeding or pregnant women
Girls 12 years and above who are menstruating and sexually active;
Children whose parent/primary caregiver does not understand English, or have a phone.

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Interventions

This study will use a randomised, double-blinded N-of-1 trial design comparing the effects of melatonin and placebo on reducing sleep latency in individual subjects. The intervention medication wil

This study will use a randomised, double-blinded N-of-1 trial design comparing the effects of melatonin and placebo on reducing sleep latency in individual subjects. The intervention medication will be immediate release melatonin taken orally 30 min before bedtime; 3 mg if child is under 40 kg, and 6 mg if child is equal to or over 40 kg. The comparator medication will be an equivalent placebo tablet, containing cellulose. Each participant will undergo three treatment periods, consisting of one week of melatonin and one week of placebo in randomized order, for a total of 6 weeks. The first day of data from each week will be discarded to allow for washout. Adherence will be monitored by pill counts at the end of the trial.